PIP SZ. 10 DISTAL

PIP SZ. 10 DISTAL
PyroCarbon PIP Total Joint System - PIP-200-10D-WW

A sterile, implantable artificial substitute for the proximal interphalangeal (PIP) joint(s) of the hand (finger) which typically has been damaged by rheumatoid, degenerative, or traumatic arthritis. The device typically consists of proximal and distal metal (e.g., titanium) stems, which may be coated with a material (e.g., hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth, for insertion into the prepared phalanges of the joint. The stems may have articulating surfaces or there may be separate metal [e.g., cobalt-chrome (Co-Cr)] and/or plastic ( e.g., polyethylene) articulating surface components. Dedicated tools for implantation may be included.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OMX

Device Name: High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis

Device Class: f

Physical State: pyrolytic carbon implant

Definition: For use in arthroplasty of the proximal interphalangeal (PIP) joint when the patient: a) has soft tissue and bone that can provide adequate stabilization and fixation under high-demand loading conditions after reconstruction; and b) needs a revision of a failed PIP prosthesis, or has pain, limited motion, or joint subluxation/disloation secondary to damage or destruction of the articular cartilage.

Submission Type ID: 6

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Implant

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: finger joints

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00885556858394

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A